菲律賓保健食品登記法規問題集
Email：mnl4ww@evershinecpa.com
或
菲律賓永輝BPO有限公司
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199
in Taiwan; Mobile: +86-139-1048-6278
in China
TEL: +886-2-27170515 E100
;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen
;
linkedin address:Dale Chen Linkedin
HLF-ph-10
請問菲律賓對於保健食品的歸類方式為何？它的正式名稱為何？不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
What are the categories of health food in Philippines? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：
菲律賓食品/膳食補充劑主管機關為食品藥物管理局(FDA)，轄下的食品監管和研究中心 (CFRR) 負責監管製造、進口、出口、分銷、銷售、邀約銷售、轉讓、促銷、廣告、贊助和/或在適當情況下的使用和食品和食品/膳食補充劑的測試，以及負責對食品的安全性、功效和質量進行研究，並製定與食品安全和質量相關的標準。
食品/膳食補充劑是指補充膳食的加工食品，其含有以下一種或多種膳食成分：維生素、礦物質、氨基酸、草本植物、其他植物、動物、人工或天然植物的膳食物質增加每日總攝入量，以符合菲律賓最新的能量和營養攝入量或國際商定的最低每日需求量。
通常以膠囊、片劑、液體、凝膠、粉末或丸劑的形式出現，不代表用作常規食品或作為膳食或飲食的唯一項目或替代藥物和藥物。
In Philippines, the food/dietary supplements competent authority is the Food and Drug Administration (FDA), and the Food Regulatory and Research Center (CFRR) under it is responsible for supervising the manufacture, import, export, distribution, sale, invitation to sell, and transfer , promotion, advertising, sponsorship and/or use, where appropriate, and testing of foods and food/dietary supplements, and responsible for conducting research into the safety, efficacy and quality of food and setting standards related to food safety and quality .
Foods/dietary supplements are processed foods that supplement the diet and contain one or more of the following dietary components: vitamins, minerals, amino acids, herbal, other plant, animal, artificial or natural plant dietary substances to increase the total daily intake to comply with the latest energy and nutrient intakes in the Philippines or internationally agreed minimum daily requirements. Usually in the form of capsules, tablets, liquids, gels, powders or pills and is not intended to be used as a regular food or as the sole item of a meal or diet or as an alternative to medicines and medications.
【參考連結】
HLF-ph-20
外國公司要到菲律賓銷售保健食品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
If a foreign company wants to sell health food in Philippines, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
需要，在菲律賓從事的食品/膳食補充劑進出口、貿易、零售和分銷的企業需要從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
1.申請人：在菲律賓從事食品/膳食補充劑的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
經營許可證(LTO)
申請文件
1. 申請表(一式兩份)
．申請人/製造商名稱
．營業地址
．電話號碼
．傳真號碼
．電子郵件
．廠址
．產品名稱
．品牌名稱
．使用的強化劑名稱、化學形式、資源
．包裝類型和標誌包裝類型和標誌
2.附件
．FDA LTO/其他機構的 LTO 或許可、有效性。
．FDA認可實驗室的主食中強化劑分析證書。
．建議使用 DSPS 的標籤。
．申請費/品牌。
．申請人/授權代表姓名、職位、簽名。
．營業執照：當營業或設立地址與商業名稱註冊地址不同時，申請人應提交營業執照副本(例如：市長許可證)。
．收入證明，例如最近經審計的財務報表和資產負債表(pdf)。
．大中型食品製造商、貿易商和分銷商(進口商、出口商和/或批發商)需要繳交風險管理計劃(RMP)。
．現場主文件(SMF)，申請LTO為大中型食品製造商(CFRR)的申請人需要繳交。
．位置圖等。
Yes. Businesses engaged in the import, export, trade, retail and distribution of food/dietary supplements in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.
1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.
2. URL: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
License to operate (LTO)
Application documents
1. Application form (in duplicate)
．Applicant/Manufacturer Name
．Business address
．Phone number
．Fax number
．Factory site
．Product
．Brand
．Enhancer name, chemical form, resource used
．Types of packaging and markings Types of packaging and markings
2. Attachment
．FDA LTO/Other Agency LTO or License, Validity.
．Certificate of Analysis for Fortifiers in Staple Foods from an FDA-recognized laboratory.
．The DSPS label is recommended.
．Application fee/brand.
．Applicant/authorized representative name, title, signature.
．Business License: When the business or establishment address is different from the registered address of the business name, the applicant should submit a copy of the business license (eg: Mayor’s Permit).
．Proof of income, such as the most recent audited financial statements and balance sheet (pdf).
．Medium and large food manufacturers, traders and distributors (importers, exporters and/or wholesalers) are required to submit a Risk Management Plan (RMP).
．Site Master File (SMF), which is required for applicants applying for LTO as a medium to large food manufacturer (CFRR).
．Location map etc.
URL:https://www.fda.gov.ph/downloadables/
【參考連結】
HLF-ph-25
HLF-ph-30
外國公司要到菲律賓銷售保健食品，可以指派菲律賓公司擔任營業代理人銷售嗎? 擔任營業代理人，其必要條件是什麼？
所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
If a foreign company wants to sell health food in Philippines, can it assign a Philippines company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以，營業代理人須為菲律賓當地企業，並取得經營許可證(LTO)。
1.申請人：在菲律賓從事食品/膳食補充劑的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
經營許可證(LTO)
申請文件
1. 申請表(一式兩份)
．申請人/製造商名稱
．營業地址
．電話號碼
．傳真號碼
．電子郵件
．廠址
．產品名稱
．品牌名稱
．使用的強化劑名稱、化學形式、資源
．包裝類型和標誌包裝類型和標誌
2.附件
．FDA LTO/其他機構的 LTO 或許可、有效性。
．FDA認可實驗室的主食中強化劑分析證書。
．建議使用 DSPS 的標籤。
．申請費/品牌。
．申請人/授權代表姓名、職位、簽名。
．營業執照：當營業或設立地址與商業名稱註冊地址不同時，申請人應提交營業執照副本(例如：市長許可證)。
．收入證明，例如最近經審計的財務報表和資產負債表(pdf)。
．大中型食品製造商、貿易商和分銷商(進口商、出口商和/或批發商)需要繳交風險管理計劃(RMP)。
．現場主文件(SMF)，申請LTO為大中型食品製造商(CFRR)的申請人需要繳交。
．位置圖等。
產品責任
1.負責將食品/膳食補充劑投放市場的公司是不良事件召回的主要責任方。
2.如果食品/膳食補充劑在原產地因健康和安全原因受到抨擊或撤回，進口商應立即採取必要措施，禁止向公眾出售、分銷或捐贈，或立即欉市場上召回、撤回或扣押。
3.經FDA 聲明為有害、不安全或有危險的保健產品的企業，應立即召回、撤回、扣押該產品，或禁止其向公眾銷售、分銷或捐贈。
4.召回的處理包含：
．食品/膳食補充劑的質量/投訴處理
．不良事件監測和基於事件的監測反應報告
．衛生產品的抽樣、測試和驗證
．許可後檢查、監測和調查
．確認通知的後評估
．廣告和宣傳材料監控
．與其他監管機構和國際合作夥伴的協調
．其他 MAH 的上市後監督活動的結果
5.一旦觸發事件發生，產品召回委員會應審查和評估健康危害。在做出召回特定食品/膳食補充劑的決定時，應考慮以下因素：
．已因使用保健產品而發生疾病、傷害、疾病或中毒。
．可能導致人群接觸的任何現有狀況。
．對預期接觸此類衛生產品的不同人群的危害。
．面臨風險的人群可能面臨的危害的嚴重程度。
．人群可能面臨的暴露風險發生的可能性。
．健康影響的短期和長期後果。
．對公眾造成嚴重欺騙的風險。
．不符合 FDA 標準。
．誤報有害物質含量。
．污染產品的材料，無論是意外的還是有意的。
．參加情況可能需要的其他因素。
6.分類：
．I 類召回：可能危及生命或可能導致嚴重健康風險、健康損害或影響(例如對健康造成永久性損害或死亡)的產品缺陷/狀況。
．II 類召回：可能導致中毒或暫時/醫學上可逆的不利健康問題或虐待的產品缺陷/狀況。
．III 級召回：可能不會對健康造成重大危害的產品缺陷/狀況，但可能因其他原因而開始撤回。
Yes. The business agent must be a local company in the Philippines and have obtained a license to operate (LTO).
License to operate (LTO)
Application documents
1. Application form (in duplicate)
．Applicant/Manufacturer Name
．Business address
．Phone number
．Fax number
．Factory site
．Product
．Brand
．Enhancer name, chemical form, resource used
．Types of packaging and markings Types of packaging and markings
2. Attachment
．FDA LTO/Other Agency LTO or License, Validity.
．Certificate of Analysis for Fortifiers in Staple Foods from an FDA-recognized laboratory.
．The DSPS label is recommended.
．Application fee/brand.
．Applicant/authorized representative name, title, signature.
．Business License: When the business or establishment address is different from the registered address of the business name, the applicant should submit a copy of the business license (eg: Mayor’s Permit).
．Proof of income, such as the most recent audited financial statements and balance sheet (pdf).
．Medium and large food manufacturers, traders and distributors (importers, exporters and/or wholesalers) are required to submit a Risk Management Plan (RMP).
．Site Master File (SMF), which is required for applicants applying for LTO as a medium to large food manufacturer (CFRR).
．Location map etc.
Product Liability
1. The company responsible for placing the food/dietary supplement on the market is the primary responsible party for the adverse event recall.
2. If the food/dietary supplement is criticized or withdrawn for health and safety reasons in the country of origin, the importer shall immediately take the necessary measures to prohibit the sale, distribution or donation to the public, or to immediately recall, withdraw or seize the market.
3. Businesses that have been declared by the FDA to be harmful, unsafe, or dangerous health care products should immediately recall, withdraw, seize, or prohibit their sale, distribution, or donation to the public.
4. The processing of recall includes:
．Food/Dietary Supplement Quality/Complaint Handling
．Adverse Event Monitoring and Event-Based Surveillance Response Reporting
．Sampling, testing and verification of hygiene products
．Post-licensing inspections, monitoring and investigations
．Post-evaluation of confirmation notices
．Monitoring of advertising and promotional materials
．Coordination with other regulatory agencies and international partners
．Results of post-market surveillance activities of other MAHs
5. Once a triggering event occurs, the Product Recall Committee shall review and evaluate the health hazards. The following factors should be considered when making a decision to recall a specific food/dietary supplement:
．Sickness, injury, illness, or poisoning has occurred as a result of the use of a health product.
．Any existing conditions that could lead to population exposure.
．Hazards to different populations expected to be exposed to such hygiene products.
．The severity of the hazard that the at-risk population may be exposed to.
．The likelihood of occurrence of exposure risks that the population may face.
．Short-term and long-term consequences of health effects.
．Risk of serious deception to the public.
．Not FDA compliant.
．Misreporting the content of hazardous substances.
．Materials that contaminate a product, either accidentally or intentionally.
．Other factors that may be required for participation.
6. Classification:
．Class I Recalls: Product defects/conditions that may be life-threatening or may cause serious health risks, health damage, or effects (such as permanent damage to health or death).
．Class II Recalls: Product defects/conditions that may cause poisoning or temporary/medically reversible adverse health problems or abuse.
．Class III Recalls: Product defects/conditions that may not pose a significant health hazard, but may have begun to be withdrawn for other reasons.
【參考連結】
https://www.fda.gov.ph/downloadables/
HLF-ph-35
HLF-ph-40
外國公司銷售到菲律賓保健食品本身，進口前需要辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？
Do foreign companies need to apply for an approval before importing health food sold to Philippines? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
在菲律賓從事的食品/膳食補充劑進出口、貿易、零售和分銷的企業需要從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
1.申請人：在菲律賓從事食品/膳食補充劑的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
經營許可證(LTO)
申請文件
1. 申請表(一式兩份)
．申請人/製造商名稱
．營業地址
．電話號碼
．傳真號碼
．電子郵件
．廠址
．產品名稱
．品牌名稱
．使用的強化劑名稱、化學形式、資源
．包裝類型和標誌包裝類型和標誌
2.附件
．FDA LTO/其他機構的 LTO 或許可、有效性。
．FDA認可實驗室的主食中強化劑分析證書。
．建議使用 DSPS 的標籤。
．申請費/品牌。
．申請人/授權代表姓名、職位、簽名。
．營業執照：當營業或設立地址與商業名稱註冊地址不同時，申請人應提交營業執照副本(例如：市長許可證)。
．收入證明，例如最近經審計的財務報表和資產負債表(pdf)。
．大中型食品製造商、貿易商和分銷商(進口商、出口商和/或批發商)需要繳交風險管理計劃(RMP)。
．現場主文件(SMF)，申請LTO為大中型食品製造商(CFRR)的申請人需要繳交。
．位置圖等。
食品/膳食補充劑產品註冊
1.申請人：在菲律賓從事食品/膳食補充劑的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：
https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
3.要求
．有效經營許可證
．所有清晰及完整的標籤或產品的掃描副本(如果適用)，包含產品和/或包裝和二次包裝(紙盒或紙板盒)
．外國代理協議(副本)
．分銷證明書(副本)
．合約(副本)
．發票(副本)
．製造商的協議備忘錄(副本)
．符合GMP的製造商註冊證書(副本)
．有效的植物檢疫證書/健康證書
．有效的ISO22000認證
．原產國簽發的HACCP證書
．獲認可規管機構證明的免費販售證明書
．穩定性研究
．成品分析證書 (COA)
．適用的安全數據(例如 LD-50 毒性測試)
．授權書
．承諾宣誓
2.其他文件(如果適用)
．技術或營養健康研究或報告
．市場調查研究
．分析、定量分析及計算證書
．在同行評審的科學期刊上發表的科學報告或研究
標籤
1. 食品標識
．產品名稱/食品名稱
．使用品牌名稱和/或商標
．完整的成分清單
．淨含量和脫水重量
．製造商、再包裝商、包裝商、進口商、貿易商和分銷商的名稱和地址
．批次識別
．儲存情況
．到期或失效日期/使用截止日期/消費前日期(建議的最後消費日期)
．食物過敏原信息
．營養成分/營養信息/營養價值
2.成分標籤
．除單一成分食品外，應在標籤上註明完整的成分清單。
．配料表應以適當的標題開頭或前面，標題應包含或包括配料一詞
．完整清單應按比例遞減順序在主顯示面板或信息面板上公佈。
．添加的水應在配料表中聲明，除非水構成配料的一部分，例如復合食品中使用的鹽水、糖漿或肉湯，並在配料表中聲明。在製造過程中蒸發的水或其他揮發性成分無需聲明。
．如果一種成分本身是兩種或多種成分的產物，則可以在成分表中聲明該複合成分，但必須立即附有括號中按比例降序排列的成分表。
．複合成分佔食品5%以下的，除在成品中具有工藝功能的食品添加劑外，無需聲明該成分。
．除非通用類別名稱提供更多信息且與現有法規/標準不衝突，否則應為成分使用特定名稱，而不是集體(通用)名稱。
．應聲明香精和調味物質。
．使用的任何焦木酸或其他人工煙味香精，應聲明為人工香精或人工煙味香精。
．著色物質應使用它們的通用名稱或食用色素或顏色(對於源自植物材料或與其相同的物質)進行聲明，對於煤焦油染料或其他合成化合物。
．食品添加劑應當標註通用名稱和功能類別。
．所有食品補充劑的標籤都應標明未批准的治療性聲明，以告知消費者食品/膳食補充劑沒有批准的療效。
3. 食品添加劑聲明
．食品添加劑必須在成分表中聲明其通用名或類別名，表明其功能類別。
．含量低於實現技術功能所需的水平，無需在成分清單中聲明。
4. 有效期/有效期
．應按以下順序清晰、醒目、清晰地印在所有產品標籤(酒精飲料除外)上：日、月、年。
．日期和年份的聲明是數字，而月份的聲明必須是文字以避免混淆(例如：到期日期：2012年1月1日或12年1月1日)。
5. 消費者投訴服務台地址
6. 營養信息
．營養成分應以表格形式，標示蛋白質、碳水化合物(包括膳食纖維和糖)、脂肪(包括飽和脂肪、反式脂肪和膽固醇)、鈉、能量的聲明價值或卡路里。
．所有營養成分的含量均應以切片、片或指定的重量或體積表示，與平均或一般食用量有關。
． 營養素的聲明也可以以每份的單位或推薦的能量和營養素攝入量百分比(RENI)或兩者來表示，前提是所有供本地消費的本地生產的食品也應標明實際價值的相應 RENI百分比以整數表示。
．碳水化合物、蛋白質、脂肪(膽固醇以毫克(mg)表示)、糖和膳食纖維應以最接近的克(g)表示。能量值應以卡路里(kcal)表示。鈉應以毫克表示。
．維生素和礦物質應以毫克或微克(mcg 或 <μg)表示。維生素 A、D 和 E 應使用國際單位 (IU)。
7.語言和易讀性要求
．食品標籤上所有信息所使用的語言必須是英語或菲律賓語或其組合。進口食品的標註為外文信息的，應附有相應的英文譯文。
．如果 FDA 允許用完現有標籤，則只能允許使用臨時不干膠標籤進行英文或菲律賓語翻譯，最長期限為六個月。所有信息都應準確、清晰，並且必須包含在一個標籤中。貼紙必須耐用，即不能輕易從標籤或包裝上取下。
．如果食品包裝的標籤太小以至於無法使用規定尺寸的字母，或者涉及次要或可選信息，則可以使用按比例縮小的字母，前提是規定的細節清晰可見，並且指定的標籤空間與包裝的大小成正比。對於其他無法容納標籤信息的小包裝，可以僅標明品牌名稱和產品名稱。但這些產品不得單獨出售，也不得用於零售。
8. 原產國標籤
．進口到菲律賓的每件外國原產物品都應使用菲律賓的任何官方語言(菲律賓語或英語)進行標記。原產國應在物品(或容器)的性質允許的情況下，在顯眼的地方以清晰、不可磨滅和永久的方式標明。
．食品的製造商、再包裝商、包裝商、進口商、貿易商或分銷商的名稱和地址應在本地製造產品的標籤上註明。
．進口產品，還應申報進口商的完整名稱、地址以及原產國。
．對於帶有外國品牌或由外國公司許可生產的產品，如果聲明外國公司的名稱和/或地址，其字體大小應不大於當地公司使用的字體。
．當食品在改變其性質的第二個國家進行加工時，進行加工的第二個國家應被視為標籤的原產國。
．如果製造商在許多城市和/或城鎮都有工廠，只要每個食品包裝都有代碼/標記來識別生產它的加工廠，地址標示公司總部。
Businesses engaged in the import, export, trade, retail and distribution of food/dietary supplements in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.
1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.
2. URL: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
License to operate (LTO)
Application documents
1. Application form (in duplicate)
．Applicant/Manufacturer Name
．Business address
．Phone number
．Fax number
．Factory site
．Product
．Brand
．Enhancer name, chemical form, resource used
．Types of packaging and markings Types of packaging and markings
2. Attachment
．FDA LTO/Other Agency LTO or License, Validity.
．Certificate of Analysis for Fortifiers in Staple Foods from an FDA-recognized laboratory.
．The DSPS label is recommended.
．Application fee/brand.
．Applicant/authorized representative name, title, signature.
．Business License: When the business or establishment address is different from the registered address of the business name, the applicant should submit a copy of the business license (eg: Mayor’s Permit).
．Proof of income, such as the most recent audited financial statements and balance sheet (pdf).
．Medium and large food manufacturers, traders and distributors (importers, exporters and/or wholesalers) are required to submit a Risk Management Plan (RMP).
．Site Master File (SMF), which is required for applicants applying for LTO as a medium to large food manufacturer (CFRR).
．Location map etc.
Food/Dietary Supplement Product Registration
1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.
2. Application webpage:
https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
3. Request
．Valid business license
．All clear and complete labels or scanned copies of products (if applicable) including product and/or packaging and secondary packaging (carton or cardboard)
．Foreign Agency Agreement (copy)
．Distribution certificate (copy)
．Contract (Copy)
．Invoice (copy)
．Manufacturer’s Memorandum of Agreement (copy)
．GMP compliant manufacturer registration certificate (copy)
．Valid phytosanitary certificate/health certificate
．Valid ISO22000 certification
．HACCP certificate issued by the country of origin
．Free selling certificate certified by a recognized regulatory body
．Stability study
．Finished Product Certificate of Analysis (COA)
．Applicable safety data (e.g. LD-50 toxicity test)
．Power of attorney
．Pledge oath
2. Additional documents (if applicable)
．Technical or Nutritional Health Research or Report
．Market research research
．Certificate in Analysis, Quantitative Analysis and Computing
．Scientific reports or research published in peer-reviewed scientific journals
Label
1. Food Labeling
．Product name/Food name
．Use of brand names and/or trademarks
．Complete Ingredient List
．Net content and dehydrated weight
．Name and address of manufacturer, repacker, packer, importer, trader and distributor
．Batch identification
．Storage situation
．Expiration or expiry date/use-by date/pre-consumption date (recommended last-consumption date)
．Food Allergen Information
．Nutrition Facts/Nutrition Information/Nutritional Value
2. Ingredient labels
．Except for single-ingredient foods, the full list of ingredients should be stated on the label.
．The ingredient list should begin or precede the appropriate title, which should contain or include the word ingredient
．The full list shall be published on the main display panel or information panel in descending order of scale.
．Added water should be declared in the ingredient list unless water forms part of an ingredient, such as brine, syrup or broth used in compound foods, and declared in the ingredient list. No declaration is required for water or other volatile components that evaporate during the manufacturing process.
．If an ingredient is itself the product of two or more ingredients, the compounded ingredient may be declared in the ingredient list, but must be immediately accompanied by a list of ingredients in descending proportional order in parentheses.
．If the compound ingredient accounts for less than 5% of the food, except for the food additive with technological function in the finished product, there is no need to declare the ingredient.
．Unless the generic category name provides more information and does not conflict with existing regulations/standards, specific names should be used for ingredients rather than collective (generic) names.
．Flavor and flavoring substances should be declared.
．Any pyrolignoic acid or other artificial tobacco flavors used should be declared as artificial flavors or artificial tobacco flavors.
．Coloring substances should be declared using their common name or food coloring or color (for substances derived from or identical to plant material), for coal tar dyes or other synthetic compounds.
．Food additives shall be marked with their generic names and functional categories.
．All food supplement labels should carry an unapproved therapeutic claim to inform consumers that the food/dietary supplement does not have an approved therapeutic effect.
3. Declaration of Food Additives
．Food additives must declare their common name or category name in the ingredient list, indicating their functional category.
．Levels below the level required to achieve technical function do not need to be declared in the ingredient list.
4. Validity Period / Validity Period
．Should be legible, prominent, and legible on all product labels (except alcoholic beverages) in the following order: day, month, year.
．Date and year declarations are numbers, while month declarations must be literals to avoid confusion (eg: due date: 1/1/2012 or 1/1/12).
5. Address of the Consumer Complaint Service Desk
6. Nutrition information
．Nutrition facts should be in tabular form with the declared value of protein, carbohydrates (including dietary fiber and sugars), fats (including saturated fat, trans fat, and cholesterol), sodium, energy, or calories.
．All nutrient content should be expressed in slices, slices, or specified weight or volume relative to average or typical serving size.
．Nutrient claims may also be expressed in units per serving or in percent of recommended energy and nutrient intake (RENI) or both, provided that all locally produced food products for local consumption are also stated with the corresponding RENI percent of actual value in Integer representation.
．Carbohydrates, proteins, fats (cholesterol expressed in milligrams (mg)), sugars and dietary fiber should be expressed to the nearest gram (g). Energy values should be expressed in calories (kcal). Sodium should be expressed in milligrams.
．Vitamins and minerals should be reported in milligrams or micrograms (mcg or <µg). International units (IU) should be used for vitamins A, D, and E.
7. Language and legibility requirements
．All information on food labels must be in English or Filipino or a combination thereof. If the imported food is marked with information in a foreign language, the corresponding English translation shall be attached.
．If the FDA allows existing labels to be used up, only temporary stickers for English or Filipino translations will be allowed for a maximum period of six months. All information should be accurate, clear, and must be included on a single label. The sticker must be durable, i.e. not easily removed from the label or packaging.
．If the label of a food package is too small to use the prescribed size letters, or involves secondary or optional information, scaled letters may be used, provided that the prescribed details are clearly visible and that the designated label space is consistent with the packaging proportional to the size. For other small packages that cannot accommodate label information, only the brand name and product name may be indicated. These products, however, may not be sold individually or for retail sale.
8. Country of Origin Label
．Every foreign origin item imported into the Philippines should be marked in any of the official languages of the Philippines (Filipino or English). The country of origin shall be clearly, indelibly and permanently marked in a conspicuous place where the nature of the article (or container) permits.
．The name and address of the manufacturer, repacker, packer, importer, trader or distributor of the food should be indicated on the label of the locally manufactured product.
．For imported products, the full name, address and country of origin of the importer should also be declared.
．For products bearing a foreign brand or licensed by a foreign company, the name and/or address of the foreign company should be declared in a font size no larger than that used by the local company.
．When the food is processed in a second country that changes its nature, the second country where the processing takes place shall be considered the country of origin of the label.
．If the manufacturer has factories in many cities and/or towns, as long as each food package has a code/mark to identify the processing plant that produced it, the address indicates the company headquarters.
【參考連結】
HLF-ph-45
HLF-ph-50
外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？需要什麼文件？
申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？？網頁？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed?Website?
在菲律賓從事的食品/膳食補充劑進出口、貿易、零售和分銷的企業，需以當地企業名義從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
1.申請人：在菲律賓從事食品/膳食補充劑的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
經營許可證(LTO)
申請文件
1. 申請表(一式兩份)
．申請人/製造商名稱
．營業地址
．電話號碼
．傳真號碼
．電子郵件
．廠址
．產品名稱
．品牌名稱
．使用的強化劑名稱、化學形式、資源
．包裝類型和標誌包裝類型和標誌
2.附件
．FDA LTO/其他機構的 LTO 或許可、有效性。
．FDA認可實驗室的主食中強化劑分析證書。
．建議使用 DSPS 的標籤。
．申請費/品牌。
．申請人/授權代表姓名、職位、簽名。
．營業執照：當營業或設立地址與商業名稱註冊地址不同時，申請人應提交營業執照副本(例如：市長許可證)。
．收入證明，例如最近經審計的財務報表和資產負債表(pdf)。
．大中型食品製造商、貿易商和分銷商(進口商、出口商和/或批發商)需要繳交風險管理計劃(RMP)。
．現場主文件(SMF)，申請LTO為大中型食品製造商(CFRR)的申請人需要繳交。
．位置圖等。
食品/膳食補充劑產品註冊
1.申請人：在菲律賓從事食品/膳食補充劑的進出口、貿易、零售和分銷的當地企業。
2.申請網頁：
https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
3.要求
．有效經營許可證
．所有清晰及完整的標籤或產品的掃描副本(如果適用)，包含產品和/或包裝和二次包裝(紙盒或紙板盒)
．外國代理協議(副本)
．分銷證明書(副本)
．合約(副本)
．發票(副本)
．製造商的協議備忘錄(副本)
．符合GMP的製造商註冊證書(副本)
．有效的植物檢疫證書/健康證書
．有效的ISO22000認證
．原產國簽發的HACCP證書
．獲認可規管機構證明的免費販售證明書
．穩定性研究
．成品分析證書 (COA)
．適用的安全數據(例如 LD-50 毒性測試)
．授權書
．承諾宣誓
2.其他文件(如果適用)
．技術或營養健康研究或報告
．市場調查研究
．分析、定量分析及計算證書
．在同行評審的科學期刊上發表的科學報告或研究
標籤
1. 食品標識
．產品名稱/食品名稱
．使用品牌名稱和/或商標
．完整的成分清單
．淨含量和脫水重量
．製造商、再包裝商、包裝商、進口商、貿易商和分銷商的名稱和地址
．批次識別
．儲存情況
．到期或失效日期/使用截止日期/消費前日期(建議的最後消費日期)
．食物過敏原信息
．營養成分/營養信息/營養價值
2.成分標籤
．除單一成分食品外，應在標籤上註明完整的成分清單。
．配料表應以適當的標題開頭或前面，標題應包含或包括配料一詞
．完整清單應按比例遞減順序在主顯示面板或信息面板上公佈。
．添加的水應在配料表中聲明，除非水構成配料的一部分，例如復合食品中使用的鹽水、糖漿或肉湯，並在配料表中聲明。在製造過程中蒸發的水或其他揮發性成分無需聲明。
．如果一種成分本身是兩種或多種成分的產物，則可以在成分表中聲明該複合成分，但必須立即附有括號中按比例降序排列的成分表。
．複合成分佔食品5%以下的，除在成品中具有工藝功能的食品添加劑外，無需聲明該成分。
．除非通用類別名稱提供更多信息且與現有法規/標準不衝突，否則應為成分使用特定名稱，而不是集體(通用)名稱。
．應聲明香精和調味物質。
．使用的任何焦木酸或其他人工煙味香精，應聲明為人工香精或人工煙味香精。
．著色物質應使用它們的通用名稱或食用色素或顏色(對於源自植物材料或與其相同的物質)進行聲明，對於煤焦油染料或其他合成化合物。
．食品添加劑應當標註通用名稱和功能類別。
．所有食品補充劑的標籤都應標明未批准的治療性聲明，以告知消費者食品/膳食補充劑沒有批准的療效。
3. 食品添加劑聲明
．食品添加劑必須在成分表中聲明其通用名或類別名，表明其功能類別。
．含量低於實現技術功能所需的水平，無需在成分清單中聲明。
4. 有效期/有效期
．應按以下順序清晰、醒目、清晰地印在所有產品標籤(酒精飲料除外)上：日、月、年。
．日期和年份的聲明是數字，而月份的聲明必須是文字以避免混淆(例如：到期日期：2012年1月1日或12年1月1日)。
5. 消費者投訴服務台地址
6. 營養信息
．營養成分應以表格形式，標示蛋白質、碳水化合物(包括膳食纖維和糖)、脂肪(包括飽和脂肪、反式脂肪和膽固醇)、鈉、能量的聲明價值或卡路里。
．所有營養成分的含量均應以切片、片或指定的重量或體積表示，與平均或一般食用量有關。
． 營養素的聲明也可以以每份的單位或推薦的能量和營養素攝入量百分比(RENI)或兩者來表示，前提是所有供本地消費的本地生產的食品也應標明實際價值的相應 RENI百分比以整數表示。
．碳水化合物、蛋白質、脂肪(膽固醇以毫克(mg)表示)、糖和膳食纖維應以最接近的克(g)表示。能量值應以卡路里(kcal)表示。鈉應以毫克表示。
．維生素和礦物質應以毫克或微克(mcg 或 <μg)表示。維生素 A、D 和 E 應使用國際單位 (IU)。
7.語言和易讀性要求
．食品標籤上所有信息所使用的語言必須是英語或菲律賓語或其組合。進口食品的標註為外文信息的，應附有相應的英文譯文。
．如果 FDA 允許用完現有標籤，則只能允許使用臨時不干膠標籤進行英文或菲律賓語翻譯，最長期限為六個月。所有信息都應準確、清晰，並且必須包含在一個標籤中。貼紙必須耐用，即不能輕易從標籤或包裝上取下。
．如果食品包裝的標籤太小以至於無法使用規定尺寸的字母，或者涉及次要或可選信息，則可以使用按比例縮小的字母，前提是規定的細節清晰可見，並且指定的標籤空間與包裝的大小成正比。對於其他無法容納標籤信息的小包裝，可以僅標明品牌名稱和產品名稱。但這些產品不得單獨出售，也不得用於零售。
8. 原產國標籤
．進口到菲律賓的每件外國原產物品都應使用菲律賓的任何官方語言(菲律賓語或英語)進行標記。原產國應在物品(或容器)的性質允許的情況下，在顯眼的地方以清晰、不可磨滅和永久的方式標明。
．食品的製造商、再包裝商、包裝商、進口商、貿易商或分銷商的名稱和地址應在本地製造產品的標籤上註明。
．進口產品，還應申報進口商的完整名稱、地址以及原產國。
．對於帶有外國品牌或由外國公司許可生產的產品，如果聲明外國公司的名稱和/或地址，其字體大小應不大於當地公司使用的字體。
．當食品在改變其性質的第二個國家進行加工時，進行加工的第二個國家應被視為標籤的原產國。
．如果製造商在許多城市和/或城鎮都有工廠，只要每個食品包裝都有代碼/標記來識別生產它的加工廠，地址標示公司總部。
Enterprises engaged in the import, export, trade, retail and distribution of food/dietary supplements in the Philippines are required to obtain a license to operate (LTO) and complete product registration from the Philippine Food and Drug Administration (FDA) in the name of the local enterprise.
1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.
2. URL: https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
License to operate (LTO)
Application documents
1. Application form (in duplicate)
．Applicant/Manufacturer Name
．Business address
．Phone number
．Fax number
．Factory site
．Product
．Brand
．Enhancer name, chemical form, resource used
．Types of packaging and markings Types of packaging and markings
2. Attachment
．FDA LTO/Other Agency LTO or License, Validity.
．Certificate of Analysis for Fortifiers in Staple Foods from an FDA-recognized laboratory.
．The DSPS label is recommended.
．Application fee/brand.
．Applicant/authorized representative name, title, signature.
．Business License: When the business or establishment address is different from the registered address of the business name, the applicant should submit a copy of the business license (eg: Mayor’s Permit).
．Proof of income, such as the most recent audited financial statements and balance sheet (pdf).
．Medium and large food manufacturers, traders and distributors (importers, exporters and/or wholesalers) are required to submit a Risk Management Plan (RMP).
．Site Master File (SMF), which is required for applicants applying for LTO as a medium to large food manufacturer (CFRR).
．Location map etc.
Food/Dietary Supplement Product Registration
1. Applicant: Local businesses engaged in import, export, trade, retail and distribution of food/dietary supplements in the Philippines.
2. Application webpage:
https://eportal.fda.gov.ph/sysFDA_WorkFlow/en/neoclassic/login/login
3. Request
．Valid business license
．All clear and complete labels or scanned copies of products (if applicable) including product and/or packaging and secondary packaging (carton or cardboard)
．Foreign Agency Agreement (copy)
．Distribution certificate (copy)
．Contract (Copy)
．Invoice (copy)
．Manufacturer’s Memorandum of Agreement (copy)
．GMP compliant manufacturer registration certificate (copy)
．Valid phytosanitary certificate/health certificate
．Valid ISO22000 certification
．HACCP certificate issued by the country of origin
．Free selling certificate certified by a recognized regulatory body
．Stability study
．Finished Product Certificate of Analysis (COA)
．Applicable safety data (e.g. LD-50 toxicity test)
．Power of attorney
．Pledge oath
2. Additional documents (if applicable)
．Technical or Nutritional Health Research or Report
．Market research research
．Certificate in Analysis, Quantitative Analysis and Computing
．Scientific reports or research published in peer-reviewed scientific journals
Label
1. Food Labeling
．Product name/Food name
．Use of brand names and/or trademarks
．Complete Ingredient List
．Net content and dehydrated weight
．Name and address of manufacturer, repacker, packer, importer, trader and distributor
．Batch identification
．Storage situation
．Expiration or expiry date/use-by date/pre-consumption date (recommended last-consumption date)
．Food Allergen Information
．Nutrition Facts/Nutrition Information/Nutritional Value
2. Ingredient labels
．Except for single-ingredient foods, the full list of ingredients should be stated on the label.
．The ingredient list should begin or precede the appropriate title, which should contain or include the word ingredient
．The full list shall be published on the main display panel or information panel in descending order of scale.
．Added water should be declared in the ingredient list unless water forms part of an ingredient, such as brine, syrup or broth used in compound foods, and declared in the ingredient list. No declaration is required for water or other volatile components that evaporate during the manufacturing process.
．If an ingredient is itself the product of two or more ingredients, the compounded ingredient may be declared in the ingredient list, but must be immediately accompanied by a list of ingredients in descending proportional order in parentheses.
．If the compound ingredient accounts for less than 5% of the food, except for the food additive with technological function in the finished product, there is no need to declare the ingredient.
．Unless the generic category name provides more information and does not conflict with existing regulations/standards, specific names should be used for ingredients rather than collective (generic) names.
．Flavor and flavoring substances should be declared.
．Any pyrolignoic acid or other artificial tobacco flavors used should be declared as artificial flavors or artificial tobacco flavors.
．Coloring substances should be declared using their common name or food coloring or color (for substances derived from or identical to plant material), for coal tar dyes or other synthetic compounds.
．Food additives shall be marked with their generic names and functional categories.
．All food supplement labels should carry an unapproved therapeutic claim to inform consumers that the food/dietary supplement does not have an approved therapeutic effect.
3. Declaration of Food Additives
．Food additives must declare their common name or category name in the ingredient list, indicating their functional category.
．Levels below the level required to achieve technical function do not need to be declared in the ingredient list.
4. Validity Period / Validity Period
．Should be legible, prominent, and legible on all product labels (except alcoholic beverages) in the following order: day, month, year.
．Date and year declarations are numbers, while month declarations must be literals to avoid confusion (eg: due date: 1/1/2012 or 1/1/12).
5. Address of the Consumer Complaint Service Desk
6. Nutrition information
．Nutrition facts should be in tabular form with the declared value of protein, carbohydrates (including dietary fiber and sugars), fats (including saturated fat, trans fat, and cholesterol), sodium, energy, or calories.
．All nutrient content should be expressed in slices, slices, or specified weight or volume relative to average or typical serving size.
．Nutrient claims may also be expressed in units per serving or in percent of recommended energy and nutrient intake (RENI) or both, provided that all locally produced food products for local consumption are also stated with the corresponding RENI percent of actual value in Integer representation.
．Carbohydrates, proteins, fats (cholesterol expressed in milligrams (mg)), sugars and dietary fiber should be expressed to the nearest gram (g). Energy values should be expressed in calories (kcal). Sodium should be expressed in milligrams.
．Vitamins and minerals should be reported in milligrams or micrograms (mcg or <µg). International units (IU) should be used for vitamins A, D, and E.
7. Language and legibility requirements
．All information on food labels must be in English or Filipino or a combination thereof. If the imported food is marked with information in a foreign language, the corresponding English translation shall be attached.
．If the FDA allows existing labels to be used up, only temporary stickers for English or Filipino translations will be allowed for a maximum period of six months. All information should be accurate, clear, and must be included on a single label. The sticker must be durable, i.e. not easily removed from the label or packaging.
．If the label of a food package is too small to use the prescribed size letters, or involves secondary or optional information, scaled letters may be used, provided that the prescribed details are clearly visible and that the designated label space is consistent with the packaging proportional to the size. For other small packages that cannot accommodate label information, only the brand name and product name may be indicated. These products, however, may not be sold individually or for retail sale.
8. Country of Origin Label
．Every foreign origin item imported into the Philippines should be marked in any of the official languages of the Philippines (Filipino or English). The country of origin shall be clearly, indelibly and permanently marked in a conspicuous place where the nature of the article (or container) permits.
．The name and address of the manufacturer, repacker, packer, importer, trader or distributor of the food should be indicated on the label of the locally manufactured product.
．For imported products, the full name, address and country of origin of the importer should also be declared.
．For products bearing a foreign brand or licensed by a foreign company, the name and/or address of the foreign company should be declared in a font size no larger than that used by the local company.
．When the food is processed in a second country that changes its nature, the second country where the processing takes place shall be considered the country of origin of the label.
．If the manufacturer has factories in many cities and/or towns, as long as each food package has a code/mark to identify the processing plant that produced it, the address indicates the company headquarters.
【參考連結】
HLF-ph-55
HLF-ph-60
經過核准登記的保健食品，進口到菲律賓要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
What documents are required when importing approved health food into Philippines? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海關
1.進口商企業首先需要取得國稅局的進口清關證書，然後進口商在海關局 (BOC) 註冊，並在客戶資料註冊系統 (CPRS) 上開設一個帳戶。網頁：https://aeo.customs.gov.ph/
2.進口清關證書有效期為三年，而海關客戶資料認證必須每年更新。CPRS 認證費用為 P1000(20 美元)，通常需要 15 個工作日來處理。
3. 菲律賓海關對進口商品徵收 12% 的增值稅 (VAT)，對價值低於 P10,000(200 美元)的商品不徵收關稅或稅款。
4.進口到菲律賓的企業在貨物到達時必須提供以下文件：
．打包清單。
．發票。
．提貨單。
．海關進口申報。
．原產地證書。
．食品和藥物管理局的產品註冊證書。
．經正式公證的估價補充聲明 (SDV) 。
．自由貿易協定 (FTA) 的原產地證明。
．貨物報關單。
．稅收抵免證書 (TCC) 或稅收借記通知單 (TDM)(如果適用) 。
．經營許可證 (LTO)
．產品註冊證書 (CPR)
．FDA 認證/通知/許可(對於那些不需要 LTO 和/或 CPR 的人)
．分析證書(如適用)
5. 進口文件
．提單/空運提單，或船舶或飛機的承運人或代理人的證明。
．商業發票、信用證或任何其他可證明付款的商業文件。
．表明貨物商業價值的商業文件。
6. 對於信用證 (L/C) 交易，需要正式完成的信用證，包括形式發票和預先海關進口關稅的單一行政文件 (SAD)。
非信用證交易需要形式發票，例如承兌匯票 (D/A)、付款單據 D/P)、開立賬戶 (OA) 或自籌資金文件。
7.文件必須連同報關人和報關行(如有)簽署並公證的 SAD 打印件一起提交給海關正式入境處 (FED) 或其同等辦公室或單位。
Customs
1. The importer business first needs to obtain the import clearance certificate from the Internal Revenue Service, and then the importer registers with the Bureau of Customs (BOC) and opens an account on the Customer Data Registration System (CPRS). Website: https://aeo.customs.gov.ph/
2. The import customs clearance certificate is valid for three years, and the customs customer data certification must be updated every year. CPRS certification costs P1000 ($20) and usually takes 15 business days to process.
3. Philippine Customs imposes a 12% Value Added Tax (VAT) on imported goods and no duties or taxes are levied on goods valued below P10,000 (US$200).
4. Enterprises importing into the Philippines must provide the following documents upon arrival of the goods:
．Packing list.
．Invoices.
．Bill of lading.
．Customs import declaration.
．Certificate of Origin.
．Product Registration Certificate from the Food and Drug Administration.
．Duly notarized Supplemental Statement of Valuation (SDV).
．Free Trade Agreement (FTA) certificate of origin.
．Goods declaration.
．Tax Credit Certificate (TCC) or Tax Debit Memo (TDM) (if applicable).
．License to operate (LTO)
．Certificate of Product Registration (CPR)
．FDA clearance/notification/license (for those who do not need LTO and/or CPR)
．Certificate of Analysis (if applicable)
5. Import Documentation
．Bill of lading/air waybill, or proof of the carrier or agent of the ship or aircraft.
．Commercial Invoice, Letter of Credit or any other commercial document to prove payment.
．A commercial document showing the commercial value of the goods.
6. For Letter of Credit (L/C) transactions, a duly completed letter of credit including pro forma invoice and Single Administrative Document (SAD) with pre-customs import duties is required. Proforma invoices are required for non-LC transactions, such as drafts of acceptance (D/A), payment documents (D/P), opening of accounts (OA), or self-funding documents.
7. The documents must be submitted to the Customs Official Entry Division (FED) or its equivalent office or unit together with a signed and notarized SAD printout of the customs broker and the customs broker (if any).
【參考連結】
https://www.fda.gov.ph/downloadables/
https://customs.gov.ph/wp-content/uploads/2016/09/Import-Transaction-Overview-Infographic_v1.0.pdf
HLF-ph-70
菲律賓保健食品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1.食品成分分析/食品營養檢測
．食品添加劑分析
．草藥製劑和膳食補充劑評估
．營養標籤和聲稱
．食品包裝檢測
．食品污染測試和殘留物測定
．食品、水和環境的微生物分析
．穩定性研究
．成品分析證書 (COA)
．適用的安全數據(例如 LD-50 毒性測試)
2. HACCP
．危害分析：從原料採收處理開始，經由加工、包裝、流通乃至最終產品提供消費者為止，進行一科學化及系統化之評估分析整個過程，以了解各種潛在性危害發生之可能性及其危害程度。
．重要管制點：對可能造成顯著危害之製程中某一點、步驟或程序，以有效監控方法(措施與條件)以預防、去除或降低食品危害至最低可以接受之程度。
．建立管制界限
．執行管制監測
．建立矯正措施
．建立記錄系統
．實施Codex HACCP (危害分析及重要管制點)食品衛生系統等
2. GMP
．建立和維護質量管理體系，以控制生產和分銷過程，確保該企業生產的所有產品均符合公佈的標準並可供人類安全食用，直至到期日。
．足夠數量的人員，具備與其分配的工作崗位相適應的專業資格，並接受過基本的GMP知識、食品安全和相關專業知識的培訓。生產負責人和質量控制負責人必須是該機構的全職員工，並且相互獨立。機構專業負責人必須具有醫學、藥學、營養學、食品安全、食品技術等專業之一的大學本科以上學歷，並具有3年以上相關專業領域的工作經驗。
．車間、設備及附屬設施系統按照使用目的設計、建造和安裝，單向原則，易於清潔，防止和最大程度減少錯誤風險，避免污垢堆積、污染等對產品產生不利影響的因素，並保持日常清潔活動。
．實施和維護有關生產、質量控制、流通和分銷的完整記錄和文件，以檢索每個產品批次的歷史記錄並記錄執行的所有其他活動。
．所有生產操作必須遵循流程和說明。在生產過程中採取檢查和監督措施，防止和避免混淆、污染和交叉污染的風險。執行操作後立即記錄結果或在記錄中完成生產階段後立即記錄結果。
．設有質量控制部門，以確保產品在適當的條件和工藝下製造並符合既定標準；已進行必要的測試；產品質量不合格不准銷售；必須監測產品的穩定性。
．檢測或委託生產的受委託方必須有足夠的廠房、設備和人員，以滿足轉讓方的要求，並符合主管管理機構對檢測或生產食品/膳食補充劑條件的規定。
．有規定投訴處理、產品召回和自檢流程；遵循程序並記錄並保留這些活動的充分記錄等。
1. Food ingredient analysis/food nutrition testing
． Food Additive Analysis
． Evaluation of herbal preparations and dietary supplements
． Nutrition Labels and Claims
． Food packaging inspection
． Food Contamination Testing and Residue Determination
． Microbiological Analysis of Food, Water and the Environment
． Stability Studies
． Finished Product Certificate of Analysis (COA)
． Applicable safety data (such as LD-50 toxicity test)
2. HACCP
．Hazard analysis: From raw material harvesting and processing, through processing, packaging, distribution, and final product delivery to consumers, a scientific and systematic evaluation and analysis of the entire process is carried out to understand the possibility of various potential hazards and their hazards degree.
． Important control point: For a point, step or procedure in the process that may cause significant harm, effective monitoring methods (measures and conditions) are used to prevent, remove or reduce food hazards to the lowest acceptable level.
．Establish regulatory boundaries
．Executive Regulatory Monitoring
．Establish corrective measures
．Establish a system of record
．Implementation of Codex HACCP (Hazard Analysis and Critical Control Point) food hygiene system, etc.
2. GMP
．Establish and maintain a quality management system to control the production and distribution process to ensure that all products produced by this business meet published standards and are safe for human consumption until the expiration date.
．A sufficient number of personnel with professional qualifications appropriate to their assigned jobs and trained in basic GMP knowledge, food safety and related professional knowledge. The Head of Production and Head of Quality Control must be full-time employees of the facility and be independent of each other. The person in charge of the institution must have a bachelor’s degree or above in one of the majors in medicine, pharmacy, nutrition, food safety, food technology, etc., and have more than 3 years of work experience in related professional fields.
．Workshops, equipment and ancillary facilities systems are designed, constructed and installed in accordance with the purpose of use, one-way principle, easy to clean, prevent and minimize the risk of errors, avoid factors such as dirt accumulation, contamination that adversely affect the product, and maintain daily cleaning activities .
．Implement and maintain complete records and documentation regarding production, quality control, circulation and distribution to retrieve the history of each product batch and record all other activities performed.
．All production operations must follow processes and instructions. Inspection and supervision measures are taken during the production process to prevent and avoid the risk of mix-ups, contamination and cross-contamination. The result is recorded immediately after the action is performed or after the production stage is completed in the record.
．There is a quality control department to ensure that products are manufactured under proper conditions and processes and meet established standards; necessary tests have been carried out; products are not of acceptable quality for sale; product stability must be monitored.
．The entrusted party for testing or entrusted production must have sufficient plant, equipment and personnel to meet the requirements of the transferor and comply with the regulations of the competent management agency on the conditions for testing or producing health food.
．Procedures for complaint handling, product recalls and self-inspection are in place; procedures are followed and adequate records of these activities are recorded and maintained, etc.
【參考連結】
https://www.fda.gov.ph/downloadables/
HLF-ph-75
HLF-ph-77
HLF-ph-80
外國子公司進口保健食品後，如果委託菲律賓的經銷商銷售，經銷商需要保健食品營業許可證嗎？
假如保健食品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？
After a foreign subsidiary imports health food and entrusts a distributor in Philippines to sell it, does the distributor need a health food business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
在菲律賓從事的食品/膳食補充劑進出口、貿易、零售和分銷的企業需要從菲律賓食品藥物管理局(FDA)獲得經營許可證(LTO)及完成產品註冊。
產品責任
1.負責將食品/膳食補充劑投放市場的公司是不良事件召回的主要責任方。
2.如果食品/膳食補充劑在原產地因健康和安全原因受到抨擊或撤回，進口商應立即採取必要措施，禁止向公眾出售、分銷或捐贈，或立即欉市場上召回、撤回或扣押。
3.經FDA 聲明為有害、不安全或有危險的保健產品的企業，應立即召回、撤回、扣押該產品，或禁止其向公眾銷售、分銷或捐贈。
4.召回的處理包含：
．食品/膳食補充劑的質量/投訴處理
．不良事件監測和基於事件的監測反應報告
．衛生產品的抽樣、測試和驗證
．許可後檢查、監測和調查
．確認通知的後評估
．廣告和宣傳材料監控
．與其他監管機構和國際合作夥伴的協調
．其他 MAH 的上市後監督活動的結果
5.一旦觸發事件發生，產品召回委員會應審查和評估健康危害。
在做出召回特定食品/膳食補充劑的決定時，應考慮以下因素：
．已因使用保健產品而發生疾病、傷害、疾病或中毒。
．可能導致人群接觸的任何現有狀況。
．對預期接觸此類衛生產品的不同人群的危害。
．面臨風險的人群可能面臨的危害的嚴重程度。
．人群可能面臨的暴露風險發生的可能性。
．健康影響的短期和長期後果。
．對公眾造成嚴重欺騙的風險。
．不符合 FDA 標準。
．誤報有害物質含量。
．污染產品的材料，無論是意外的還是有意的。
．參加情況可能需要的其他因素。
6.分類：
．I 類召回：可能危及生命或可能導致嚴重健康風險、健康損害或影響(例如對健康造成永久性損害或死亡)的產品缺陷/狀況。
．II 類召回：可能導致中毒或暫時/醫學上可逆的不利健康問題或虐待的產品缺陷/狀況。
．III 級召回：可能不會對健康造成重大危害的產品缺陷/狀況，但可能因其他原因而開始撤回。
Businesses engaged in the import, export, trade, retail and distribution of food/dietary supplements in the Philippines need to obtain a license to operate (LTO) from the Philippine Food and Drug Administration (FDA) and complete product registration.
Product Liability
1. The company responsible for placing the food/dietary supplement on the market is the primary responsible party for the adverse event recall.
2. If the food/dietary supplement is criticized or withdrawn for health and safety reasons in the country of origin, the importer shall immediately take the necessary measures to prohibit the sale, distribution or donation to the public, or to immediately recall, withdraw or seize the market.
3. Businesses that have been declared by the FDA to be harmful, unsafe, or dangerous health care products should immediately recall, withdraw, seize, or prohibit their sale, distribution, or donation to the public.
4. The processing of recall includes:
．Food/Dietary Supplement Quality/Complaint Handling
．Adverse Event Monitoring and Event-Based Surveillance Response Reporting
．Sampling, testing and verification of hygiene products
．Post-licensing inspections, monitoring and investigations
．Post-evaluation of confirmation notices
．Monitoring of advertising and promotional materials
．Coordination with other regulatory agencies and international partners
．Results of post-market surveillance activities of other MAHs
5. Once a triggering event occurs, the Product Recall Committee shall review and evaluate the health hazards.
The following factors should be considered when making a decision to recall a specific food/dietary supplement:
．Sickness, injury, illness, or poisoning has occurred as a result of the use of a health product.
．Any existing conditions that could lead to population exposure.
．Hazards to different populations expected to be exposed to such hygiene products.
．The severity of the hazard that the at-risk population may be exposed to.
．The likelihood of occurrence of exposure risks that the population may face.
．Short-term and long-term consequences of health effects.
．Risk of serious deception to the public.
．Not FDA compliant.
．Misreporting the content of hazardous substances.
．Materials that contaminate a product, either accidentally or intentionally.
．Other factors that may be required for participation.
6. Classification:
．Class I Recalls: Product defects/conditions that may be life-threatening or may cause serious health risks, health damage, or effects (such as permanent damage to health or death).
．Class II Recalls: Product defects/conditions that may cause poisoning or temporary/medically reversible adverse health problems or abuse.
．Class III Recalls: Product defects/conditions that may not pose a significant health hazard, but may have begun to be withdrawn for other reasons.
【參考連結】
https://www.fda.gov.ph/downloadables/
HLF-ph-85
聯繫我們
Email：mnl4ww@evershinecpa.com
或
菲律賓永輝BPO有限公司
聯絡人: 陳中成 總經理 in 台+中+英;專利師;企管碩士+企管博士
Mobile: +886-933920199
in Taiwan; Mobile: +86-139-1048-6278
in China
TEL: +886-2-27170515 E100
;
Wechat id:evershiinecpa;
Line Id: evershinecpa
Skype: daleccchen
;
linkedin address:Dale Chen Linkedin
全球永輝服務據點參考資料:
永輝100%關係企業
永輝總部、臺北永輝、廈門永輝、北京永輝、上海那靈、深圳常新、紐約永輝、加州永輝、德州永輝、鳳凰城永輝、東京永輝、首爾永輝、河內永輝、越南胡志明、曼谷永輝、新加坡永輝、吉隆玻永輝、雅加達永輝、馬尼拉永輝、墨爾本永輝、澳洲雪梨、孟加拉永輝、新德里永輝、印度孟買、杜拜永輝、法蘭克福永輝、巴黎永輝、倫敦永輝、荷蘭永輝、西班牙永輝、義大利永輝、羅馬尼亞永輝、多倫多永輝、墨西哥永輝。
其他已提供中文化服務城市：
邁阿密、亞特蘭大、俄克拉荷馬、密歇根、西雅圖、特拉華；
柏林; 斯圖加特;布拉格；布加勒斯特；班加羅爾；泗水；
高雄、香港、深圳、東關、廣州、清遠、永康、杭州、蘇州、崑山、南京、重慶、許昌、青島、天津。
永輝潛在可服務城市 (2個月籌備期)：
我們為IAPA會員所,總部在倫敦，全球300個會員所，員工約1萬人。
我們為LEA會員所,總部在美國芝加哥，全球600個會員所，員工約2萬8千人。
Evershine is local Partner of ADP Streamline® in Taiwan.
(版本:2022/03)
更多城市更多服務 請點擊 網站導覽
